Dentin Hypersensitivity
Conditions
Brief summary
Hypersensitivity
Interventions
DRUGTriclosan, Silicon dioxide, fluoride
Brush twice daily
Brush twice daily
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female subjects, ages: 12 years or older. * Availability for the eight-week duration of the study. * Two sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession. * Qualifying response to Tactile stimuli (Yeaple Probe) as defined by a score between 10-50 grams of force. * Qualifying response to the Air Blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale. * Subjects need to satisfy the qualifying response to stimuli for both parameters assessed (Tactile or Air Blast) on at least two teeth to be entered into the study. * Good general health with no known allergies to products being tested. * Use of a non-desensitizing dentifrice for one month prior to entry into the study. * Signed Informed Consent Form.
Exclusion criteria
* Gross oral pathology, chronic disease, or history of allergy to test products. * Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months. * Sensitive teeth with a mobility greater than one. * Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures. * Regular use of anticonvulsants, antihistamines, sedatives, tranquilizers, anti-inflammatory drugs, or analgesics. * Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past one month. * Current participation in any other clinical study. * Allergies to triclosan, or oral care products, personal care consumer products, or their ingredients. * Medical condition which prohibits not eating/drinking for 4 hours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypersensitivity Tactile(Yeaple Probe) | 4 weeks | Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth |
| Hypersensitivity Tactile (Yeaple Probe) | 8 weeks | Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Air Blast Hypersensitivity (4 Week) | 4 weeks | Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:0No subject response to stimulus1responds but will continue2responds and moves or requests discontinuation3Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth. |
| Air Blast Hypersensitivity (8 Week) | 8 weeks | Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:0No subject response to stimulus1responds but will continue2responds and moves or requests discontinuation3Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth. |
Countries
United States
Participant flow
Recruitment details
subjects were recruited by the PI at the clinical site
Pre-assignment details
subjects were screened for medical and oral health criteria and then entered a 1 week washout before study treatment period.
Participants by arm
| Arm | Count |
|---|---|
| A-Experimental Toothpatse fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula) | 314 |
| B -Control Toothpaste Fluoride/Triclosan control toothpaste | 312 |
| Total | 626 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 12 | 13 |
Baseline characteristics
| Characteristic | B -Control Toothpaste | A-Experimental Toothpatse | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 7 Participants | 9 Participants |
| Age, Categorical >=65 years | 4 Participants | 6 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 306 Participants | 301 Participants | 607 Participants |
| Age Continuous | 41.4 years STANDARD_DEVIATION 12.1 | 40.6 years STANDARD_DEVIATION 13.4 | 41 years STANDARD_DEVIATION 12.7 |
| Region of Enrollment United States | 312 participants | 314 participants | 626 participants |
| Sex: Female, Male Female | 233 Participants | 226 Participants | 459 Participants |
| Sex: Female, Male Male | 79 Participants | 88 Participants | 167 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 314 | 4 / 312 |
| serious Total, serious adverse events | 0 / 314 | 0 / 312 |
Outcome results
Primary
Hypersensitivity Tactile (Yeaple Probe)
Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-Experimental Toothpatse | Hypersensitivity Tactile (Yeaple Probe) | 31.90 Units on a scale | Standard Deviation 12.26 |
| B -Control Toothpaste | Hypersensitivity Tactile (Yeaple Probe) | 17.28 Units on a scale | Standard Deviation 8.86 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Hypersensitivity Tactile(Yeaple Probe)
Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-Experimental Toothpatse | Hypersensitivity Tactile(Yeaple Probe) | 19.81 units on a scale | Standard Deviation 9.56 |
| B -Control Toothpaste | Hypersensitivity Tactile(Yeaple Probe) | 13.94 units on a scale | Standard Deviation 6.42 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Secondary
Air Blast Hypersensitivity (4 Week)
Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:0No subject response to stimulus1responds but will continue2responds and moves or requests discontinuation3Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-Experimental Toothpatse | Air Blast Hypersensitivity (4 Week) | 1.61 units on a scale | Standard Deviation 0.62 |
| B -Control Toothpaste | Air Blast Hypersensitivity (4 Week) | 2.18 units on a scale | Standard Deviation 0.6 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Secondary
Air Blast Hypersensitivity (8 Week)
Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:0No subject response to stimulus1responds but will continue2responds and moves or requests discontinuation3Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-Experimental Toothpatse | Air Blast Hypersensitivity (8 Week) | 0.89 units on a scale | Standard Deviation 0.69 |
| B -Control Toothpaste | Air Blast Hypersensitivity (8 Week) | 1.80 units on a scale | Standard Deviation 0.72 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA